MAUDE Adverse Event Report: MERGE HEALTHCARE MERGE PACS; PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

Model Number MERGE PACS V6.6.2.2

Device Problem Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/05/2015

Event Type  malfunction  

Event Description

Merge pacs (picture archiving communication system) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography.On (b)(6) 2015 a customer reported that some patient priors included incorrect information after a data migration.The customer was receiving a print out from the ris system and found that mrn numbers were migrated over with the old numbers.This resulted in exams in incorrect folders.Merge pacs qualifies studies by mrn when processing a08 (patient update) and a34 (patient merge) requests from a his/ris.By default, if an a08 or a34 request is received that has an mrn that matches a patient but has the wrong patient name, the request will be rejected by the merge pacs.Merge pacs can be configured, however, to not check to see if the patient name stored in its database matches that sent by the his/ris and will instead return all studies that have an mrn that matches that sent by the his/ris (a process known as "global update").Merge was able to provide the necessary data so that the customer could do a comparison and identify duplicates to make sure the exams were in the correct folder.There was no report of patient injury.Reference: (b)(4).

• Brand Name: MERGE PACS
• Type of Device: PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
• Manufacturer (Section D): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge drive; hartland WI 53029
• Manufacturer Contact: michael diedrick ; 900 walnut ridge drive; hartland, WI 53029 ; 2629123570
• MDR Report Key: 5543837
• MDR Text Key: 41825416
• Report Number: 2183926-2016-00040
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MERGE PACS V6.6.2.2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1